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NCT Number: NCT02719561

Fatigue Intervention Co-design Study in Teenagers and Young Adults With Cancer

Fatigue is one of the most common and distressing symptoms in teenage and young adult cancer patients. Despite this, there has been virtually no research evaluating treatment for cancer-related fatigue in this young patient group. The investigators are undertaking a small qualitative study to co-design a fatigue intervention, that will then be evaluated in future research to assess its effectiveness.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This small qualitative study will involve 7-10 patients who are within one year of completing cancer treatment, as well as some parents. Participants will be recruited from one centre, the Cambridge Teenage and Young Adult cancer Principal Treatment Centre. The three phases will involve a) participants being interviewed individually and attending a focus group, b) patients receiving the prototype co-designed intervention, and c) participants being interviewed after the intervention to provide feedback to allow further refinement of the intervention. The intervention will be delivered by an Allied Health Professional in the setting that participants have chosen. It is likely to involve, at a minimum, education about fatigue and support with increasing activity. It will not include administration of any medication.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • Aged 16-27 with a diagnosis of cancer
  • Currently or previously known to the Cambridge Teenage and Young Adult cancer service
  • Primary cancer treatment completed within one year of recruitment OR on maintenance treatment for leukaemia.
  • A screening score of ≥5 in a 10-item numerical rating scale of fatigue severity over the last month
  • Able to give informed consent

Parents:

  • The parent of a patient participant or a patient who would be eligible to participate
  • The patient consents to the parent being approached about the study
  • The parent is able to give informed consent

Exclusion criteria

  • Current participation in another clinical trial

Treatment and study plan

Fatigue Intervention

Behavioral

The Fatigue Intervention will include education, energy conservation and activity promotion

Primary outcomes

  1. Participant-reported feedback on design content as assessed via interviews

    Time frame: 3 months

  2. Participant-reported feedback on design acceptability as assessed via interviews

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Anna Spathis

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2016
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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